Associate Director, Chemical Development
- Waltham, MA
Site Name: USA - Massachusetts - Waltham
Posted Date: Jan 17 2020
Are you energized by a challenging role in Chemical Process and Development? If so the Associate Director, Chemical Development role would be a great opportunity to consider.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
The Associate Director, Chemical Development will be responsible for the development, implementation and management of robust, cost effective, and safe processes for the manufacture of small molecule and Oligonucleotide Active Pharmaceutical Ingredients (APIs).
The incumbent will be responsible for the technical development, support, innovative solutions and commercialization of drug substances using an external network of providers. This position is integral to the advancement of GSK's growing portfolio of drug candidates and technology programs, and will provide technical oversight, expertise and guidance of externalized drug substance related activities.
The scope of the role encompasses a wide breadth of lifecycle, ranging from early stage development, late stage development, process validation, early commercial manufacturing, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role will be critical in ensuring we optimize development, reduced risk profiles and ultimately accelerate the development cycle of assets.
S/he will be expected to manage these activities using an outsourcing model in a virtual CMC environment.
S/he will be expected to manage these activities using an outsourcing model and to work within a cross-functional team environment of external service providers and internal team members to help define project scope and ensure successful delivery with regards to process improvements, technical troubleshooting, quality, timelines and budget. S/he will be responsible for building/maintaining strong working relationships with their respective staff and management. The candidate will identify opportunities and activities that can enable the scale up of drug candidates for pre-clinical and clinical studies as well as supporting validation activities when progressing to late stage.
The successful candidate will report directly to the Senior Director, Chemical Development.
- Provide leadership in support of Active Pharmaceutical Ingredients (API) development programs.
- Collaborate and coordinates in cross-functional teams, both internally and at CROs (contract research organizations) to develop robust, scalable, cost effective and safe chemical processes.
- Responsible for deliveries of drug substance to support IND enabling toxicology studies as well as cGMP API for Phase appropriate clinical studies.
- To develop and optimize chemical processes for the manufacturing of drug substance which will be suitable for progressing from small scale to production scale in a high throughput production environment
- Focused upon development of chemical processes to avoid reactions and processes that do not scale well, e.g. hazardous reactions.
- Conduct route scouting, reaction optimization, and scale-up demonstration using an outsourcing model.
- Recommends the development of economical, state-of-the-art techniques to isolate, characterize, purify and produce drug substance by keeping up to date with the scientific literature, regulatory guidelines and industry advances
- Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate.
- Recommends the development of more convergent synthetic strategy to produce drug substance, and save cost and reduce waste generation
- Partner with internal and external stakeholders to perform risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles to define the design space and develop overall control strategy. Construct and manage controlled experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes.
- Ensures that scientifically-sound technical data are generated that enables key decisions on early and late stage development projects.
- Supervises the implementation of development activities at CROs via reviewing and writing of clear and concise procedures
- Preparation of technology transfer packages to support technical transfer activities between CROs.
- Team member to perform technical audits of CMC vendors.
Why you? Basic Qualifications
- PhD in synthetic organic chemistry with 8+ years of experience in pharmaceutical research and development in the biotech or pharma industry, with significant experience in the areas of process development, process characterization, process validation and product life cycle management or BS/MS with equivalent experience is required.
- Demonstrated history working in a virtual CMC development and/or commercialization environment working with CMC partnerships with global providers.
- Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
- Experience with process characterization or design space studies using DoE statistical analysis tools.
- First-hand experience in collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments.
- Must be able to determine appropriate resources for resolution of problems, to have strong organizational and planning skills and work independently.
- Desire to acquire new knowledge in chemistry, pilot and plant operations in different contract research organizations.
- Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA).
- Strong computer, scientific, and organization skills.
- Ability to travel up to 30% both domestically and internationally.
- Ability to problem solve using innovative thinking and good decision making.
- Ability to innovate, implement change and drive for results.
- Strong collaboration and communication skills; ability to build and maintain good working relationships with internal and external stakeholders.
- Flexibility in handling work flow in a multi-tasking environment.
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
- Preferred: - Thorough understanding of oligonucleotide chemistry, including phosphoramidite based synthesis methods, deprotection, purification and isolation methods. Ability to apply organic chemistry to designing and developing new synthetic routes.
- Preferred: - Synthesis of oligonucleotides including synthesis, cleavage and deprotection, purification, tangential flow filtration, and lyophilization
- Preferred: - Proficiency operating automated oligonucleotide synthesis equipment, such as GE OligoProcess, OligoPilot 400, and Dr. Oligo.
- Preferred: - First-hand experience in oligonucleotide analytical / quality control, including MALDI-Tof and ESI mass spectrometry, HPLC, UPLC and NMR analysis and capillary gel electrophoresis.
- Preferred: - Proficiency operating oligonucleotide purification equipment, such as Dionex, Aekta, and Gilson HPLCs.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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